Radiesse™

Prof. Kirwan was a trainer and instructor at the Radiesse Workshop ‘The art of total facial contouring with RADIESSETM on behalf of Bioform Medical Europe B.V., Clifton Ford Hotel, Welbeck Street, London, March 19, 2005.

RADIESSETM is used for facial restoration and augmentation. The implant is formulated from Calcium Hydroxylapatite (CaHA)) because it is the quintessential biocompatible implant material.

RADIESSETM is an injectable cohesive implant for soft tissue augmentation that is scientifically engineered to be used in connective tissue.

The implant is a mixture of an aqueous based gel, blended with spherical particles of synthetic calcium hydroxylapatite (CaHA). The gel carrier suspends the CaHA particles and allows them to be readily delivered by injection needles. The average size of the spherical particles is 30 microns.

RADIESSETM is CE approved for facial restoration and augmentation.
RADIESSETM combines biocompatibility and ease of use for longer lasting subdermal injection augmentation of facial features.

The synthetic CaHA is identical in composition to the mineral portion of human bone and teeth and has an extensive history of safe use in many medical applications such as vocal fold medialization, stress urinary incontinence and alveolar ridge augmentation.

The gel components are U.S.P. grade pharmaceutical ingredients that are classified Generally Recognized As Safe (GRAS [CRF Title 21 section 182]) by the United States Food and Drug administration.

The implant is non-toxic, non-antigenic and biocompatible. The implant site remains soft and flexible and does not calcify or have any evidence of bone formation.

The implant is durable, flexible, and is a biocompatible scaffold for tissue infiltration. The CaHA particles are surrounded by a thin fibroplastic stroma as tissue ingrowth occurs.

Functional Characteristics

Advanced ceramic processing techniques are utilized to prepare the CaHA particles. The particles are segregated into a narrow size range. The narrow particle size maximizes the relative amount of volume between the particles. The space between the granules becomes infiltrated with fibrous tissue resulting in an implant similar to the surrounding tissue.

Extensive research has been conducted on CaHA as an implant material. Studies that have been conducted for as long as seven years demonstrate that CaHA implants do not calcify or ossify (become bone) in soft tissue. Calcification was not observed in clinical studies of BioForm implants of more than five years.

The size of the particles was selected to minimize migration potential and to allow easy injection through e relatively small needle. Should any particles become phagocytized, the particles are degraded in situ to calcium and phosphate ions like small fragments of bone.

RADIESSETM has a shelf life of two years. The gel carrier allows the CaHA to maintain in suspension during storage and injection so that consistent product is injected at all sites.

The implant is stable over a broad range of temperatures for ease of shipping storage and use. The high viscosity of the gel minimizes leakage from the injection site. After injection, the gel gradually degrades in situ by being phagocytized and is replaced by cellular infiltration. This may result in some loss of volume requiring further augmentation. Absorption of gel is thought to occur at about six months after treatment.

RADIESSETM is recommended for long term correction of naso-labial and marionette lines as well as for lip augmentation. Treatment requires local anesthetic injection and the procedure takes approximately thirty minutes. Ice is applied afterwards to reduce swelling. Redness may be present for two to three days after treatments. Bruising may occur particularly after lip injection and pre-treatment with Arnica and Bromolein may be helpful. Patients who are currently taking medications such as aspirin or aspirin related products should discontinue treatment three weeks before RadianceTM FN therapy.

RADIESSETM is not recommended in patients who have a bleeding disorder, are on anti-thrombotic medication, have an infection in the area to be treated, and are known to be hypersensitive to any of the constituents of RADIESSETM or who may be pregnant.